(332 days)
The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.
The provided text is a 510(k) summary for the HansBiomed Corp. SurFuse™ and ExFuse™ devices. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for AI/ML-driven software as a medical device.
Therefore, the requested information specifically related to acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth types are not available in the provided document, as these are primarily associated with the validation of AI/ML diagnostic or prognostic algorithms.
The document discusses safety and performance in a more general sense for a bone void filler product, focusing on biocompatibility, osteoinductivity, and osteoconductivity, rather than an AI/ML algorithm's analytical or clinical performance.
Here's a breakdown of what can be extracted and what is missing:
The device is a physical medical device (resorbable bone void filler), not an AI/ML software. Therefore, the parameters typically used to describe AI/ML studies are not relevant or present.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for quantitative metrics in an AI context. Instead, the acceptance is based on demonstrating safety (biocompatibility, viral inactivation) and performance (osteoinductivity, osteoconductivity) through established biological and in vivo models.
- Reported Device Performance:
- Safety:
- Donor bone obtained from AATB-certified tissue banks, screened for infectious viruses.
- Manufacturing and sterilization processes validated to inactivate HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV), and Porcine Parvovirus (PPV).
- Biocompatibility testing (according to ISO 10993) performed, demonstrating devices are safe, nontoxic, and biocompatible.
- Performance:
- Osteoconductive ability: Successfully grown bone in the in vivo rabbit spinal model.
- Osteoinductive potential:
- Demonstrated new bone growth within muscle tissue in the athymic (nude) rat muscle pouch model.
- Evaluated with a surrogate, in vitro BMP-2 ELISA assay, with results correlated with successful bone formation in the athymic rat for the same lots.
- Each lot will be evaluated for osteoinductive potential using the in vitro assay.
- Safety:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified for human data. For preclinical studies:
- Rabbit spinal model: Sample size not specified.
- Athymic (nude) rat muscle pouch model: Sample size not specified.
- Data Provenance: Preclinical animal models (rabbit and rat). Human data (if any for testing) is not described. Donor bone is sourced from AATB-certified tissue banks in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this type of device relies on biological outcomes in animal models (e.g., bone formation observed histologically) and in vitro assays, not on expert human interpretation of medical images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for performance):
- Observation of bone formation in vivo (rabbit spinal model, athymic rat muscle pouch model).
- Results of in vitro BMP-2 ELISA assay correlated with in vivo bone formation.
- Ground Truth (for safety/biocompatibility):
- Viral inactivation validation studies.
- ISO 10993 biocompatibility testing results.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this physical device.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.